Institute of Validation Technology Validation Week-Philadelphia

Institute of Validation Technology
Validation Week- Philadelphia

Session 4: Best Practice to Implement Process
Validation in Device Manufacturing Enterprise-
wide
Tanya Fletcher-Scott
Validation Manager- Greenville SC Solutions Facility

Tanya.Fletcher-Scott@Bausch.com
October 24, 2012
CONFIDENTIAL [1]
Agenda
£  Getting Started-Overview

£  Process Validation
£  Enterprise wide Roll Out of Process Validation
£  Interactive Exercise
Look out for

the
Best
Practice
[2]
Getting Started-Overview
o  The Rules- Review of Standards and Guidances for

Process Validation of Devices
o  Tools- Risk Assessments and Statistics
o  The Team- Don’t go it alone!
o  The Docs- Documenting the process validation

activities
[3]
The Rules- Review of Standards and Guidances for Process
Validation of Devices:
•  21 CFR 820 Quality System Regulators
•  ISO, EN ISO 13485 Medical devices- Quality management

systems- Requirements for regulatory purposes
•  ISO, EN ISO 14971 Medical devices-Application of risk

management to medical devices
Best Practice:
• ISO, EN ISO 9001 Quality management systems —Requirements
Know your
regs and
guidances
[4]
The Rules- Review of Standards and Guidances for Process
•  GHTF, Global Harmonization Task Force- Quality management

Systems-Process Validation Guidance*
•  SOR/98-282 Canadian Medical Regulators

Best Practice:
Know your
•  93/42/EEC Medical Device Directive
regs and
guidances
*Copy provided as bonus material
[5]
The Rules- Review of standards and guidances for Process
21 CFR 820 Quality System Regulators
Sec. 820.70 Production and process controls.

b-Production and process changes. Each manufacturer shall
establish and maintain procedures for changes to a specification,
method, process, or procedure. Such changes shall be verified or
where appropriate validated according to 820.75 (Process
Validation), before implementation and these activities shall be
documented. Changes shall be approved in accordance with 820.40
(Document controls).
[6]
Sec. 820.75 Process Validation.

a- Where the results of a process cannot be fully verified by
subsequent inspection and test, the process shall be validated with
a high degree of assurance and approved according to established
procedures. The validation activities and results, including the date
and signature of the individual(s) approving the validation and
where appropriate the major equipment validated, shall be
documented.
b- Each manufacturer shall establish and maintain procedures for

monitoring and control of process parameters for validated
process to ensure that the specified requirements continues to
be met.
[7]
ISO, EN ISO 13485 Medical devices- Quality management systems-

Requirements for regulatory purposes
7 Product realization, 7.1 Planning of product realization

The organization shall plan and develop the processes needed for product
realization. Planning of product realization shall be consistent with the
requirements of the other processes of the quality management system. In
planning product realization, the organization shall determine the following, as
appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes, documents, and provide resources specific to
the product;
c) required verification, validation, monitoring, inspection and test activities
specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and
resulting product meet requirements
[8]
ISO, EN ISO 13485 Medical devices- Quality management systems-

Requirements for regulatory purposes
7.5.2 Validation of processes for production and service provision

The organization shall validate any processes for production and service
provision where the resulting output cannot be verified by subsequent monitoring
or measurement. This includes any processes where deficiencies become
apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned
results. The organization shall establish arrangements for these processes
including, as applicable
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records and
e) revalidation.
[9]
Tools- Risk Assessments and Statistics Best
Practice:
Use your
statisticians
Statistics
Sec. 820.250 Statistical techniques.

(a)  Where appropriate, each manufacturer shall establish and maintain
procedures for identifying valid statistical techniques required for
establishing, controlling, and verifying the acceptability of process
capability and product characteristics.
(b) Sampling plans, when used, shall be written and based on a valid
statistical rationale. Each manufacturer shall establish and maintain
procedures to ensure that sampling methods are adequate for their
intended use and to ensure that when changes occur the sampling
plans are reviewed. These activities shall be documented.
[ 10 ]
Tools- Risk Assessments and Statistics
ISO 13485
8 Measurement, analysis and improvement, 8.1 General
The organization shall plan and implement the monitoring, measurement,

analysis and improvement processes needed
a)  to demonstrate conformity of the product,
b) to ensure conformity of the quality management system, and
c)to maintain the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical

techniques, and the extent of their use.
[ 11 ]
Risk Analysis
Risk Assessments
ISO 14971 Medical devices —

Application of risk management Risk Evaluation
to medical devices
Risk Control
The ISO Standard defines risk as
combination of the probability of
occurrence of harm and the
severity of that harm
Evaluation of overall
residual risk acceptability
Risk Management Report
Production and post-

production information
[ 12 ]

Risk Management Tools
•  Preliminary Hazard Analysis (PHA) is a technique that
can be used early in the development process to
identify the hazards, hazardous situations, and events
that can cause harm when few of the details of the
medial device design are known.
•  Fault Tree Analysis (FTA) is especially useful in safety

engineering, early in the development stages, for the
identification and prioritization of hazards and
hazardous situations as well as for analyzing adverse
events.
[ 13 ]

Risk Management Tools
•  Failure Mode and Effects Analysis (FMEA) and Failure
Mode, Effects and Criticality Analysis (FMECA) are
techniques by which an effect or consequences of
individual components are systematically identified and is
more appropriate as the design matures.
•  Hazard and Operability Study (HAZOP) and Hazard

Analysis and Critical Control Point (HACCP) are typically
used in the latter stages of the development phase to
verify and then optimize design concepts or changes.
[ 14 ]
The Team- Don’t go it alone!
The types of products manufactured in the

Greenville facility are lens care solutions.
When we are conducting a process validation

to support a product transfer or significant
formulation change, we need the support of a
cross functional group inclusive of corporate
and site wide subject matter experts.
[ 15 ]
The Team- Don’t go it alone!
The Global Harmonization Task Force- Quality Management Systems –
Process Validation Guidance suggests the following subject matter team
members:
•  Quality Assurance*
Best
•  Engineering* Practice:
•  Manufacturing* Project Managers
are key to any
•  Laboratory (Chemistry and Microbiology)* success tech
•  Technical Services transfer
•  Research & Development*
•  Regulatory Affairs*
•  Clinical Engineering
•  Purchasing/Planning
•  Process Excellence / Statistician*
•  Project Manager*
*B+L’s typical team core members for major process validation projects
[ 16 ]
The Docs- Documenting the process validation activities
a- Where the results of a process cannot be fully verified

by subsequent inspection and test, the process shall be
validated with a high degree of assurance and approved
according to established procedures. The validation
activities and results, including the date and signature of
the individual(s) approving the validation and where
appropriate the major equipment validated, shall be
documented.
[ 17 ]
Process Validation Guidance suggests the following elements in your
process validation protocols:
Elements Validation IQ OQ PQ PV
Strategy
Identification of the process to be validated X X X X X
Identification of device(s) to be manufactured X X X X X
using this process

Objective and measurable criteria for a X X X X X
successful validation
Identification of operators and required operator X X
Best
qualification Practice:
Validation
Strategies are a
great tool for ‘big
scope’ projects
[ 18 ]
Strategy
X
Length and duration of the validation
X X
Shifts, operators, equipment to be used in the
process
X X X X
Any subjective criteria used to evaluate the
product
X X
Identification of utilities for the process
equipment and quality of the utilities
X X X X X
Complete description of the process
[ 19 ]
Strategy
X X X X
Relevant specifications that relate to the
product, components, manufacturing
materials, etc
X X
Process parameters to be monitored, and
methods for controlling and monitoring*
X X
Product characteristics to be monitored and
method for monitoring*
X X
Any subjective criteria used to evaluate the
product
*Use of a Control Plan is a great tool and best practice. Example included in bonus material
[ 20 ]
Strategy
X X X X X
Definition of what constitutes non-
conformance for both measurable and
subjective criteria
X X X X
Statistical methods for data collection and
analysis
X
Consideration of maintenance and
repairs of manufacturing equipment
X
Criteria for revalidation
When it’s all done, generate the final report summarizing all
requirements, results, issues and conclusions
[ 21 ]
Agenda

[ 22 ]
Process Validation
o  Creating a strategy/validation plan
o  Strategies for new and existing products
o  Runs and samples
o  When are you done?
[ 23 ]
Process Validation
Creating a strategy/validation plan
A Validation plan which defines what needs to be validated (i.e.

equipment, systems and processes) and how validation needs will be
met for a given project.
The strategy also provides a roadmap to follow ensuring the

requirements are defined and agreed upon up-front and that all
requirements are met prior to implementation or launch
Best
Practice:
Wait until you
have created or
updated your risk
assessment
before generating
a strategy.
[ 24 ]
Process Validation
Creating a strategy/validation plan
B+L’s validation systems does not require validation strategies for smaller, less
complex validation projects whose strategy can be fully detailed within a protocol.
The strategy is useful to communicate completion of validation strategy activities

and results of the testing performed to support product Launch or Design Change
Implementation
<Let’s review the sample validation strategy in your bonus material>
[ 25 ]
Process Validation
Strategies for new and existing products
New Products
Per ISO 9001, all new products must under Design and development
which includes:
•  Planning
•  Design and development inputs
•  Design and development outputs
•  Design and development review
•  Design and development verification
•  Design and development validation*
•  Control of design and development changes*
*At the completion of the design and development validation and

before the control of design changes, product transfer and process
validation occurs.
[ 26 ]
Process Validation
New Products
During the product transfer process, the product is being evaluated
at the manufacturing site for scale up.
It is at this stage that the use of statistician can help evaluate

process capability and readiness for process validation. Also
helpful with defining acceptance criteria, number of Best
samples, etc. Practice:
During the product
transfer stage there
Risk analysis can be a great tool in defining worse needs to be high
case conditions a process can potential see in routine engagement with site
validation
manufacturing. These failure modes can be tested
in product evaluation and/or validation trials.
(reference validation strategy risk mitigation table)

[ 27 ]
Process Validation
New Products
Process Validation Readiness should include the following:
• Design review confirms process is capable
• All prerequisite validations are complete (e.g. equipment,

facility, software, etc.)
• Process control plan has been created or updated*
• Risk analysis has been updated
*<Let’s review the sample control plan in your bonus material>

[ 28 ]
Process Validation
[ 29 ]
Process Validation
New Products
Process Validation Readiness should include the following:
• All procedures, batch records, inspection plans,
specifications, drawings are updated and approved.
• All impacted personnel are trained on procedure, batch

records, inspection plans, etc.
• All raw materials are procured and in approved status
• All new suppliers are in approved status

<Let’s review the sample readiness form in your bonus material>
[ 30 ]
Process Validation
[ 31 ]
Process Validation
Existing Products
Existing products are defined as validated products that have
been transferred to the manufacturing site for routine
manufacture. For validations involving any existing product,
B+L follows a global change management process.
Sec. 820.70 Production and process controls.
b-Production and process changes. Each manufacturer shall establish
and maintain procedures for changes to a specification, method,
process, or procedure. Such changes shall be verified or where
appropriate validated according to 820.75 (Process Validation), before
implementation and these activities shall be documented. Changes shall
be approved in accordance with 820.40 (Document controls).
[ 32 ]
Process Validation
Existing Products
B+L’s global change management software tracks all changes for

existing products.
Depending on the scope of the change; a limited, extensive or full

revalidation may need to be conducted. A key element of change control
is the impact analysis. The impact analysis considers the impact of the
change to the risk management file. Best
Practice:
A Validation
representative
needs to evaluate
changes impacting
validated state.
[ 33 ]
Process Validation
Existing Products
A useful tip is to work with your Research and Development group
or Technical Services group to evaluate the capability of the
product device after proposed change.
Pros:
• Better process understanding
• Greater confidence in the process to pass when you go into live
validation.
Cons:
• May require additional equipment, line time, resources, lab support to
generate data
• Cost of material/product that may need to be scrapped
It’s a Risk decision
[ 34 ]
Process Validation
Runs and Samples
How many runs do we need???
[ 35 ]
Process Validation
Runs and Samples
How many samples do we need to take???
[ 36 ]
Process Validation
Runs and Samples
Can we runs this concurrent with production???
[ 37 ]
Process Validation
Runs and Samples
Can we runs this concurrent with production???
It depends on the scope, level of risk and confidence we have in the

process. It’s a question of risk!
[ 38 ]
Process Validation
Runs and Samples
For the number of runs, we use 3 as a starting point. We let our risk
assessment drive the number of runs needed. Example:
There is a process change that will impact the manufacturing of a

formulation in 2 different tanks. Our engineering data indicates that although
the 2 tanks are the same size they are both designed differently and have
different heating and agitation profiles. A risk analysis indicates that heating
and agitation may have significant impact on product acceptance. For this
process validation a minimum of 6 runs (3 runs/tank) may be recommended
in addition to engineering trials to confirm capability of the formulation.
[ 39 ]
Process Validation
Runs and Samples
In sampling, we target confidence level of at least 90%. We also let our

risk analysis drive the number and type of samples needed. There
needs to be an understanding of what’s important to your process.
Let’s illustrate this point with the validation of Product XYZ
[ 40 ]
Process Validation
Runs and Samples
Overview of product and manufacturing process for Product XYZ
£  Raw Materials: Best

Practice:
•  Sterile Water A key to the
•  NaCL sampling rationale
is found in the
•  Raw Material A CQA’s. They
define what’s
•  Raw Material B (new) important
•  Excipients
£  Critical Quality Attributes (CQAs).

•  Solution is safe and effective for intended purpose (attribute or go/no-go)
•  Batch is homogeneous (variable data)
•  Raw Materials A and B must meet label claim (attribute or go/no-go)
[ 41 ]
Process Validation
Runs and Samples

Product XYZ
Bulk Sterile Packaging
Compounding Filling
Step 1
• Purified Water
Step 3
• Add Excipents
• Mix and Sterile filter Raw
• Heat sterilize mixture
Materials A and B
CPPs=batch temp,
agitation speed 19,000 L CPP=batch temp, mix time
Tank
Step 4
Step 2 • Mix dissolve and Sterile

filter NaCL and excipients
• Mix, dissolve and Sterile
filter excipents CPP=batch temp, mix
time
CPP=batch temp, mix time
CPP=Critical Process Parameter
[ 42 ]
Process Validation
Runs and Samples

Product XYZ
Compounding Filling
CPP= Line length,

product conditioning
19,000 L volume, filling speed, etc.
Tank
[ 43 ]
Case Study- Process Validation for Product XYZ
Runs and Samples

Compounding Filling
• Our product and process risk assessment identified both the bulk compounding
and sterile filling process steps as having the highest potential risk. Critical Quality
Attributes (CQAs).
•  Solution is safe and effective for intended purpose (most likely impacted in bulk
compounding and sterile filling process)
•  Batch is homogeneous (most likely impacted in bulk compounding)
•  Raw Materials A and B must meet label claim (most likely impacted in bulk
compounding)
• We focused more effort (sampling and runs) on these high risk process steps
during scale up and process validation
[ 44 ]
Process Validation
Runs and Samples

Compounding Filling
• Based on historical data and information from our risk assessments, the heaviest
use of statistics (sampling) was focused on the bulk compounding and sterile filling
processes as we needed to demonstrate a high level of assurance at these stages.
• We used process capability data from similar products and development work to
establish standard deviations for Raw Materials A and B.
• Our sample size was based on the use of standard deviations from engineering
trials, 90% Confidence
• For batch and bottle homogeneity we demonstrated with 90%Confidence that
batch and bottle sample sets were homogeneous.*
[ 45 ]
Process Validation
When are you done?
Now that the execution is complete with your

Process Validation and Final Report has been
written and approved,
Are You Done?
[ 46 ]
Process Validation
When are you done?
According to GHTF - Quality Management Systems Process
Validation Guidance, you should maintain a state of
validation:
•  Monitor and control
•  Changes in processes and/or product
•  Continued state of control
[ 47 ]
Process Validation
When are you done?
Most companies including B+L are using the product quality review
process to confirm medical device products are maintained in a state of
control. Key attributes include:
•  In process and final product manufacturing trend data
•  Complaints
•  Non-conformances
•  Corrective Preventive Actions
•  Stability
•  Changes and subsequent validations

[ 48 ]
Agenda

[ 49 ]
Enterprise wide Roll Out of Process Validation
o  Enterprise-wide policies and procedures
o  Quality System standardization, design management, change

management and validation
o  Train personnel
[ 50 ]
Enterprise-wide policies and procedures
The CFR requires established procedures to conduct process validation and

support monitoring and control of process parameters.

a- Where the results of a process cannot be fully verified by subsequent
inspection and test, the process shall be validated with a high degree of
assurance and approved according to established procedures. The
validation activities and results, including the date and signature of the
individual(s) approving the validation and where appropriate the major
equipment validated, shall be documented.
b- Each manufacturer shall establish and maintain procedures for

monitoring and control of process parameters for validated process to
ensure that the specified requirements continues to be met.
[ 51 ]
Best practices for a multi-site / global company to deploy process validation

procedures is Enterprise-wide policies and procedures:
Pros:
• Provides clear instruction for ‘how things are done’.
• Offers consistent approach to validation to train to and follow regardless of site
location, manufacturing platform, products manufactured
• Presents to regulators the company’s position on process validation
• Capitalize on best practices at each site. Best
• Ensures alignment to guidances, standards and industry best Practice:
practices In addition to policies
and procedures,
templates provide
consistency
[ 52 ]
Cons:
• Difficult to gain consensus with multiple sites who have always ‘done it
their way’.
• Procedures and templates may not be flexible to meet needs of different
products, manufacturing platforms
• Learning curve and time to implement
Tips for Enterprise-Wide roll out are:

• Getting engagement and feedback from stakeholders at the
manufacturing site. Feedback should be from each type of
manufacturing site.
• Deploy procedures and templates on a trial basis to ‘validate’ its use.
• Allow extended phase in period (60-90 days) for training
[ 53 ]
Quality System standardization, design management, change

The success of any Validation Program is contingent on a

healthy Quality System.
ISO 9001 identifies the some of the Quality Systems evaluated during
management review:
5.6.2 Review input- The input to management review shall include information
on:
a) results of audits, (Internal and External Audits)
b) customer feedback, (Complaints)
c) process performance and product conformity, (NonConformance Management)
d) status of preventive and corrective actions, (NonConformance Management)
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and (Change Mgmt)
g) recommendations for improvement. (Continuous Improvement)
[ 54 ]

ISO 9001 state the following responsibilities of Management Review:
5.6.3 Review output- The output from the management review shall include any
decisions and actions related to:
a) improvement of the effectiveness of the quality management system and its
processes,
b) improvement of product related to customer requirements, and
c) resource needs.
[ 55 ]

Standardization of key quality systems like design management, change

management and validation ensures:
• Provides clear instruction for ‘how things are done’.
• Offers consistent approach to train and follow regardless of site location,

manufacturing platform, products manufactured
• Presents to regulators the company’s position on key quality systems
• Ensures alignment to guidances and standards
<Reference a sample global final report template in bonus material>
[ 56 ]
Agenda

[ 57 ]
Interactive Exercise
Firm is rebranding a legacy medical device product in a

new bottle.
Product is a sterile liquid. Bottle is being sourced from a

new supplier. Bottle requires a different sterilization
method. New equipment will be needed to run this bottle.
Validation needs to be conducted to launch to ‘new
product’.
What will the validation strategy be?
[ 58 ]
•  Product ABC is currently filled in an oval and opaque HDPE. New
bottle is round, transparent (without colorant) HDPE
•  Sterilization Method for current bottle is Ethylene Oxide. New bottle

will require gamma irradiation
•  Bottle will be filled in Fill Room C. Fill Room C only has change
parts for oval bottles.
•  Instead of using the checkweighing system, the firm would like to

use fill volume sensors that were always integrated on Fill Room C
but never used because firm uses opaque bottles.
•  Original validation for Product ABC was conducted 15 ago.
[ 59 ]
Each team, take 5-10 minutes to develop a validation strategy.
Demonstrate the use of the following:
•  Success criteria
•  Team Members
•  Any necessary pre-work (engineering, develop studies, etc.)
•  Training
•  Proposed risk analysis
•  Proposed statistics
•  Process steps to focus validation effort

[ 60 ]
Questions???
[ 61 ]

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Institute of Validation Technology

Validation Week- Philadelphia

Validation Manager- Greenville SC Solutions Facility

October 24, 2012

£ Getting Started-Overview

Look out for

o The Rules- Review of Standards and Guidances for

o Tools- Risk Assessments and Statistics

o The Team- Don’t go it alone!

o The Docs- Documenting the process validation

• 21 CFR 820 Quality System Regulators

• ISO, EN ISO 13485 Medical devices- Quality management

• ISO, EN ISO 14971 Medical devices-Application of risk

• GHTF, Global Harmonization Task Force- Quality management

• SOR/98-282 Canadian Medical Regulators

*Copy provided as bonus material

21 CFR 820 Quality System Regulators

Sec. 820.70 Production and process controls.

Sec. 820.75 Process Validation.

b- Each manufacturer shall establish and maintain procedures for

ISO, EN ISO 13485 Medical devices- Quality management systems-

7 Product realization, 7.1 Planning of product realization

ISO, EN ISO 13485 Medical devices- Quality management systems-

7.5.2 Validation of processes for production and service provision

Sec. 820.250 Statistical techniques.

Tools- Risk Assessments and Statistics

The organization shall plan and implement the monitoring, measurement,

b) to ensure conformity of the quality management system, and

c)to maintain the effectiveness of the quality management system.

This shall include determination of applicable methods, including statistical

ISO 14971 Medical devices —

Risk Management Report

Production and post-

Tools- Risk Assessments and Statistics

• Fault Tree Analysis (FTA) is especially useful in safety

Tools- Risk Assessments and Statistics

• Hazard and Operability Study (HAZOP) and Hazard

The types of products manufactured in the

When we are conducting a process validation

Sec. 820.75 Process Validation.

a- Where the results of a process cannot be fully verified

Identification of the process to be validated X X X X X

Identification of device(s) to be manufactured X X X X X

using this process

£ Getting Started-Overview

o Creating a strategy/validation plan

o Strategies for new and existing products

o Runs and samples

o When are you done?

Creating a strategy/validation plan

A Validation plan which defines what needs to be validated (i.e.

The strategy also provides a roadmap to follow ensuring the

Creating a strategy/validation plan

The strategy is useful to communicate completion of validation strategy activities

<Let’s review the sample validation strategy in your bonus material>

Strategies for new and existing products

*At the completion of the design and development validation and

Strategies for new and existing products

It is at this stage that the use of statistician can help evaluate

(reference validation strategy risk mitigation table)

Strategies for new and existing products

• All prerequisite validations are complete (e.g. equipment,

£  Getting Started-Overview

o  The Rules- Review of Standards and Guidances for

o  Tools- Risk Assessments and Statistics

o  The Team- Don’t go it alone!

o  The Docs- Documenting the process validation

•  21 CFR 820 Quality System Regulators

•  ISO, EN ISO 13485 Medical devices- Quality management

•  ISO, EN ISO 14971 Medical devices-Application of risk

•  GHTF, Global Harmonization Task Force- Quality management

•  SOR/98-282 Canadian Medical Regulators

•  Fault Tree Analysis (FTA) is especially useful in safety

•  Hazard and Operability Study (HAZOP) and Hazard

£  Getting Started-Overview

o  Creating a strategy/validation plan

o  Strategies for new and existing products

o  Runs and samples

o  When are you done?

• All prerequisite validations are complete (e.g. equipment,

• Process control plan has been created or updated*

• Risk analysis has been updated

• All impacted personnel are trained on procedure, batch

• All raw materials are procured and in approved status

• All new suppliers are in approved status

£  Raw Materials: Best

£  Critical Quality Attributes (CQAs).

Step 2 • Mix dissolve and Sterile

•  Monitor and control

•  Changes in processes and/or product

•  Continued state of control

•  In process and final product manufacturing trend data

•  Corrective Preventive Actions

•  Changes and subsequent validations

£  Getting Started-Overview

o  Enterprise-wide policies and procedures

o  Quality System standardization, design management, change

• Provides clear instruction for ‘how things are done’.

• Offers consistent approach to train and follow regardless of site location,